A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 333
- 试验地点
- 11
- 主要终点
- Median Percent Change in Seizure Frequency
研究概览
简要总结
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.
详细描述
Approximately 333 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (High Dosage, Medium Dosage and Placebo). After completing the Double-blind Treatment Period, participants will either transition into the RAP-219-FOS-901 long-term safety (open-label extension) study or enter the 8-week post-treatment Follow-up Period of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75
- •BMI 18-45 kg/m2
- •Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
- •Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
- •Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
- •Ability to keep accurate daily focal seizure records using an e-diary
排除标准
- •Known hypersensitivity or prior exposure to RAP-
- •Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
- •Anticipated need for surgery during the study period
- •Medical history of any of the following:
- •generalized epilepsy
- •focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type
- •psychogenic nonepileptic seizure (PNES)
- •status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).
- •epilepsy surgery within 12 months prior to Visit 1 (Day -56).
- •Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
研究组 & 干预措施
Active Arm- Medium Dose
RAP-219 daily tablets administered orally
干预措施: RAP-219 (Drug)
Placebo
Inert comparator matching the active treatment
干预措施: Placebo (Other)
Active Arm- High Dose
RAP-219 daily tablets administered orally
干预措施: RAP-219 (Drug)
结局指标
主要结局
Median Percent Change in Seizure Frequency
时间窗: End of double-blind treatment period (end of week 14) vs Baseline
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
次要结局
- ≥50% seizure frequency reduction responder rates(End of double-blind treatment period (end of week 14) vs Baseline.)
- Longest Seizure Free Interval(Across the entire 14-week double-blind treatment period)